Maker of heart device admits cover-up

Updated 10:00 pm, Thursday, June 12, 2003

SAN FRANCISCO -- A manufacturer of heart surgery devices pleaded guilty yesterday to covering up malfunctions that may have led to 12 deaths and complications in many other cases.

Endovascular Technologies Inc. of Menlo Park, Calif., a subsidiary of Indianapolis-based Guidant Corp., agreed to pay $92.4 million in civil and criminal penalties, the largest fine of its kind, to settle the federal charges. The company also pleaded guilty to 10 felonies, including shipping misbranded products and making false statements to government regulators.

Criminal charges against company executives are being considered, prosecutors said.

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"Because of the company's conduct, thousands of patients underwent surgeries without knowing the risks they faced," U.S. Attorney Kevin Ryan said at a news conference. "These actions were criminal."

The problems involved the Ancure "stent-graft" device, which is used during operations to treat heart aneurysms. They were resolved after the device was voluntarily recalled in March 2001 and before it was reintroduced five months later, the company said in a statement.

The company said none of the more than 18,000 patients who have Ancure Endograft implants is at risk because the problems highlighted by the case occurred during surgery. A Food and Drug Administration official confirmed that complications from the device resulted when doctors were inserting it or removing it.

The device, inserted through the groin, was designed to let doctors operate on the heart without opening the chest. The FDA first approved it in 1999.

According to court documents unsealed yesterday, federal prosecutors said the device often malfunctioned and the company asked doctors to use it in ways not approved by the government. In many instances, sales representatives in the operating room asked surgeons, in an effort to remove the lodged device, to break it and remove it a piece at a time. When that failed, the chest would have to be opened.

The equipment, which resembles a fishing pole, is used to position a patch on the heart.

The nine misbranding criminal counts stem from the company never reporting to the FDA that it was recommending unauthorized practices.

"The delivery system would become stuck or lodged in the patient's body," prosecutor Matt Jacobs told U.S. District Judge Susan Illston. He said the procedure was not approved by the FDA and required at least 57 invasive surgeries to remove the system from the patient.

Outside of court, Ryan and Jacobs said the government learned of the issue after seven company employees notified executives of Endovascular and its parent, Guidant. Jacobs said neither Guidant nor Endovascular alerted the government to the whistle-blowers' complaints.

The company was charged with failing to report as many as 2,600 malfunctions of the $10,000 device during surgery, thus preventing the public and physicians from learning about "recurring malfunctions and other risks." The company also was accused of failing to report that other, more invasive surgeries were required after the device failed.

One criminal charge said the company misled the FDA and reported only 172 malfunctions since the product's introduction. The complaint alleged that the company had records of 2,628 malfunctions, including reports that the malfunctions may have led to 12 deaths and 57 traditional open heart surgeries.

The company said it already has set aside money to pay the fine levied under yesterday's settlement.